Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01622062 | Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen | PHASE3 | COMPLETED | 600 | — | — | Jun 29, 2012 | Nov 14, 2018 | Apr 25, 2022 | 1 | Philippines |
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Patients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 2 | EXPERIMENTAL | Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 3 | ACTIVE_COMPARATOR | Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Name | Type | Description |
|---|---|---|
| PVRV | BIOLOGICAL | 0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally |
| PVRV and pERIG Favirab® | BIOLOGICAL | 0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) |
Inclusion Criteria: For all patients: * Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site. For adults: * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. ...